FDA Approves Neffy 1 mg Nasal Spray for Pediatric Patients

The FDA has approved ARS Pharmaceuticals’ neffy 1mg (epinephrine nasal spray) for the treatment of type 1 allergic reactions, including anaphylaxis, for pediatric patients who are at least four years old and weigh 33 to 65 lbs., according to a recent news release. Neffy is the first significant innovation for this population in more than 35 years.

Type 1 allergic reactions include anaphylaxis, which is a severe, life-threatening allergic reaction that can be caused by foods such as shellfish, tree nuts or insect stings. Symptoms may appear as hives, itching, vomiting, difficulty breathing and loss of consciousness. The only treatment for anaphylaxis is epinephrine, which was previously only available as an injection.

This approval is based on a single-arm pharmacology study in pediatric patients. Side effects occurred in at least 10% of patients and included nasal discomfort, headache and throat irritation.

In the United States, about 1 in 13 children have a food allergy, and at least 2 in 5 children have experienced an allergic reaction severe enough to go to the emergency room, according to data from the Centers for Disease Control and Prevention.

Despite the effectiveness of epinephrine for anaphylaxis, 56% of caregivers worry about giving their child an injection, according to a study published in Allergy.

“The availability of a needle-free epinephrine option for children is a breakthrough in the treatment of severe allergic reactions,” David Fleischer, M.D., section head of Allergy & Immunology and pediatrics professor at Children’s Hospital Colorado, said in the news release. “Many people wait to administer epinephrine until symptoms progress or take antihistamines as a first line of defense because they are afraid of injection.”

Neffy 1 mg is expected to be available in the United States by the end of May 2025. Patients and caregivers can access financial support, treatment and insurance information through the neffyConnect program. Through the savings program, most commercially insured patients will pay no more than $25 for two single-use neffy devices. The co-pay savings card can be accessed on neffy.com. If neffy is not covered by the patient's’ insurance, two doses can be purchased for $199 through BlinkRx using a GoodRx coupon. Some eligible patients may be able to access neffy 1 mg at no cost through the ARS Pharma Patient Assistance Program.

Neffy was first FDA-approved as a 2 mg dose in August 2024 for the emergency treatment of anaphylaxis in children and adults weighing at least 66 lbs.